OR WAIT null SECS
December 20, 2021
The agency recommended granting conditional marketing authorization for use of Nuvaxovid in people 18 years of age and older.
December 03, 2021
While supply chain disruptions have resulted in many alterations to workplace practices, they have also presented an opportunity to get ahead of changes to the EU’s upcoming revision of Annex 1.
November 19, 2021
Jordi Serrat, Product & Technology Director, Azbil Telstar talks about the role of disruptive and digital technologies in aseptic processing.
November 18, 2021
Rafael Beaus, Global Consultancy Manager, Azbil Telstar, discusses Annex 1 and trends in aseptic production.
November 17, 2021
Luke Stockhausen, Lead Process Engineer, CRB, talks about technological advances, processing line changes, and new solutions to overcome challenges in aseptic processing.
November 16, 2021
Richard Denk, Senior Consultant Aseptic Processing and Containment, SKAN AG, discusses the evolution of aseptic processing with a particular focus on isolators.
November 15, 2021
Patrick Nieuwenhuizen, Senior Manager/Consultant, PharmaLex, discusses changes to regulatory requirements, quality risk management, audits, and operational considerations of aseptic processing.
November 11, 2021
The agency is recommending the authorization of Ronapreve (casirivimab/imdevimab) and Regkirona (regdanvimab), two monoclonal antibody drugs, for treating COVID-19.
November 10, 2021
The agency is evaluating Moderna’s application for use of Spikevax in children aged 6 to 11.
November 02, 2021
An annual survey on inspections and audits has revealed opportunities to use more flexible approaches to optimize processes.
